Brief Introductory Head Note Summary of Case, Factual Background
This case involves a legal battle over a patent application for a special kind of medicine delivery system designed to release drugs slowly into the body over time. The companies involved, Amylin Pharmaceuticals, LLC and AstraZeneca Pharmaceuticals LP, both from the United States, wanted to protect their invention in India. Their invention is a ready-to-use injection that contains tiny spheres (called microspheres) suspended in an oil-based liquid. These spheres hold a drug called exenatide, which helps treat diabetes, along with a bit of sugar to keep it stable. The idea is to make the drug last longer in the body so patients do not have to inject themselves every day. The factual background starts with the companies filing their patent application in India on May 1, 2011, based on an international application they had submitted earlier. They claimed priority from a U.S. application dated September 4, 2008. The invention aims to solve problems like the need for frequent injections, unstable drug mixtures, and complicated preparation before use. It promises benefits such as longer shelf life, steady drug release, and easier use for patients.
Procedural Detail
The patent office in Delhi examined the application and issued a first report on March 29, 2017, pointing out issues. The companies responded on September 27, 2017, with changes to their claims. Then, on October 16, 2017, they got a notice for a hearing, which happened on November 13, 2017. After the hearing, they submitted more written arguments and updated claims on November 28, 2017. Despite this, on July 10, 2018, the Assistant Controller rejected the application, saying it lacked originality and fell under a rule that blocks patents for mere discoveries of new forms of known substances without better results. Feeling this was wrong, the companies appealed to the Delhi High Court under a law that allows challenges to patent decisions. The appeal was heard by a single judge, who looked at all the arguments, prior inventions cited, and legal rules before giving a decision on November 24, 2025.
Core Dispute
The main fight was whether the invention was truly new and clever enough to deserve a patent. The patent office said no, because it seemed obvious based on four earlier documents (called prior arts, labeled D1 to D4) that described similar ideas. These documents talked about drug delivery using tiny spheres, oils, and the drug exenatide. The companies argued that their mix was unique: it used a specific oil (non-water-based with certain fatty acids) that kept everything stable and ready-mixed, unlike the others which needed mixing or had drawbacks like quick drug bursts or short shelf life. They said the office ignored their explanations and data showing better stability and ease of use. Another key point was a law that says you cannot patent a new form of a known drug unless it works much better therapeutically. The companies claimed their version did, but the office disagreed, saying no proof of better healing effects was shown, just better storage or release. The court had to decide if combining ideas from those old documents would naturally lead someone skilled in the field to this invention, or if it was a real step forward.
Detailed Reasoning and Discussion by Court Including on Judgement with Complete Citation Referred and Discussed for Reasoning
The court started by laying out what both sides said. The companies pointed out that the patent office did not properly look at their final changes and arguments about why their invention was not obvious. They went through each prior document: D1 (a U.S. publication from 2004) talked about spheres for drug delivery but not the specific oil or ready-mix setup; D2 (another U.S. publication from 2008) focused on liquid mixes without spheres and even warned against sphere-based systems; D3 (a journal article from 2000) used different drugs and a water-based carrier; D4 (an international publication from 2005) aimed at low-burst release but without the oil carrier. They argued no one skilled would combine these to get their invention, and they had patents in other countries like the U.S. and China. The patent office countered that D1 suggested oils and spheres, D2 added exenatide and sugar for stability, D3 showed in-place forming spheres, and D4 had similar release controls. They said mixing these ideas was straightforward for someone in the field, and no real proof of better healing was shown, just practical perks.
The judge then analyzed if the rejection was fair. First, on originality (under the law's Section 2(1)(ja), which requires an inventive step), the court used a method from a past case called Hoffmann-La Roche Ltd. v. Cipla Ltd., decided in 2016 by the Delhi High Court (full citation: Hoffmann-La Roche Ltd. v. Cipla Ltd., (2016) 65 PTC 1 (Del.)). This case sets steps to check if something is obvious: identify what a skilled person knows, spot differences from old ideas, and see if bridging them needs creativity. Applying this, the court found D1 hints at non-water oils like "fixed oils" (which often mean triglyceride oils) and mentions oleic acid (a longer-chain fatty acid), making shorter chains like C6-C12 seem logical tweaks. D2 clearly has exenatide (0.1-10%) and sugars for stability, plus talks of long-lasting formulas. D3 uses PLGA spheres forming on-site with similar carriers. D4 adds sugar in spheres for steady release and names exendin-4 (same as exenatide). The court said a skilled person, starting from D1's need for better spheres, would look to D2 for the drug and stability, D3 for forming methods, and D4 for low-burst tricks. To back this, the judge cited Astrazeneca AB and Another v. Torrent Pharmaceuticals Ltd, a 2020 Delhi High Court decision (full citation: Astrazeneca AB and Another v. Torrent Pharmaceuticals Ltd, 2020 SCC OnLine Del 1446), which says no "teaching away" if a document prefers one way but does not rule out others—here, D1 prefers some oils but opens to fixed oils. Another case, Fresenius Kabi Oncology Limited v. Glaxo Group Limited & Anr, from the Intellectual Property Appellate Board in 2013 (full citation: Fresenius Kabi Oncology Limited v. Glaxo Group Limited & Anr, 2013 SCC OnLine IPAB), was used to explain that alternatives in old documents do not discourage trying them unless strongly warned against. Finally, Bristol-Myers Squibb Holdings Unlimited Company and Others v. BDR Pharmaceuticals International Pvt. Ltd., another 2020 Delhi High Court ruling (full citation: Bristol-Myers Squibb Holdings Unlimited Company and Others v. BDR Pharmaceuticals International Pvt. Ltd., 2020 SCC OnLine Del 1700), warned against hindsight—picking bits from old documents only after seeing the new invention. But the court felt the connections were natural, not forced.
On the other ground (Section 3(d), which stops patents for new forms of known drugs without proven better healing), the court noted no data showed the mix cured diabetes better, just stored or released better. The companies' foreign patents did not sway things, as Indian law is stricter. The judge quoted the office's order, agreeing it reasoned well enough, even if copying some arguments.
Decision
The court decided against the companies. It said the invention seemed obvious to someone skilled, based on combining old ideas without real creativity. The rejection for lacking an inventive step and not showing better therapeutic effects was correct. So, the appeal was dismissed, and the patent office's decision from July 10, 2018, stood. No costs were awarded.
Concluding Note
This ruling shows how strict Indian patent law is on drug inventions, especially those tweaking known ideas. It stresses that improvements must be truly clever and prove real health benefits, not just convenience. For companies, it means gathering strong data early and watching how offices combine old documents. Overall, it balances innovation with preventing monopolies on minor changes.
Case Title: Amylin Pharmaceuticals, LLC and Anr. Vs. Assistant Controller of Patents and Designs Order date: 24/11/2025 Case Number: C.A.(COMM.IPD-PAT) 76/2022 Neutral Citation: 2025:DHC:1042 Name of Court: High Court of Delhi at New Delhi Name of Hon'ble Judge: Hon'ble Mr. Justice Tejas Karia
Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation. Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
Suggested Titles:
- Navigating Inventive Step in Pharmaceutical Patents: Lessons from Amylin Pharmaceuticals v. Controller of Patents
- Obviousness and Section 3(d) Hurdles: Analyzing the Delhi High Court's Rejection of Sustained-Release Drug Formulations
- Patent Appeals in India: A Deep Dive into Prior Art Mosaics and Therapeutic Efficacy Requirements
- From Microspheres to Courtrooms: The Battle Over Non-Aqueous Carriers in Diabetes Drug Innovations
- Judicial Scrutiny of Biotech Patents: Upholding Standards in Amylin's Sustained-Release Formulation Case
In a significant ruling on patent law, the High Court of Delhi at New Delhi, through Hon'ble Mr. Justice Tejas Karia, dismissed the appeal in the case titled Amylin Pharmaceuticals, LLC and Anr. vs. Assistant Controller of Patents and Designs, case number C.A.(COMM.IPD-PAT) 76/2022, on November 24, 2025. The case stemmed from the rejection of a patent application for "Sustained Release Formulations Using Non-Aqueous Carriers," a ready-to-use injectable microsphere formulation containing the diabetes drug exenatide, designed for prolonged drug release without needing on-site mixing.
The appellants, U.S.-based pharmaceutical companies Amylin Pharmaceuticals, LLC and AstraZeneca Pharmaceuticals LP, had filed the application in India in 2011, claiming priority from a 2008 U.S. filing. They argued that their invention offered advantages like stability, ease of use, and a specific non-aqueous carrier of medium-chain triglycerides (C6 to C12 fatty acids), which the patent office overlooked in its 2018 rejection order. They contended the formulation involved an inventive step over prior arts (D1 to D4) and did not fall under Section 3(d) of the Patents Act, which bars patents for new forms of known substances without enhanced efficacy.
The respondent, the Assistant Controller, maintained that the invention was obvious, combining elements from existing documents: D1 on microsphere delivery, D2 on exenatide with sugar stabilizers, D3 on in-situ PLGA microspheres, and D4 on low-burst release profiles. The court, after detailed analysis citing precedents like Astrazeneca AB vs. Torrent Pharmaceuticals (2020) and Bristol-Myers Squibb vs. BDR Pharmaceuticals (2020), agreed that a person skilled in the art would find the combination straightforward without creativity. It held the application lacked an inventive step under Section 2(1)(ja) and upheld the rejection, noting no interference was needed despite foreign grants in countries like the U.S. and China.
This decision reinforces India's strict standards for pharmaceutical patents, emphasizing the need for genuine innovation over minor modifications.
Disclaimer:This is for general information only and should not be construed as legal advice as it may contain human errors in perception and presentation: Advocate Ajay Amitabh Suman, IP Adjutor (Patent & Trademark Attorney), High Court of Delhi
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